Argon Medical Devices Hemostasis Valve Recall for Incomplete Pouch Seals
Argon Medical Devices is recalling Hemostasis Valves because incomplete pouch seals may cause a loss of sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of loss of sterility, which is a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Argon Medical Devices, Inc. is recalling Hemostasis Valves, 7F-9F, REF 049297, due to a potential defect in the packaging. The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product.
The recall involves 49,130 units of the product, identified by Lot number 11232311. The product is labeled as single use only and non-sterile, requiring further processing. Distribution was nationwide, including military and government channels, as well as foreign distribution to Canada, Australia, the Netherlands, and Spain.
The U.S. Food and Drug Administration has classified this as a Class II recall. Healthcare facilities and distributors should stop using the affected product and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Argon Medical Devices Hemostasis Valve, 7F-9F, REF 049297, Single Use Only, Non-Sterile-Further Processing Required, 250 valves/bag which is placed in a box. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.
- Manufacturer
- Argon Medical Devices, Inc
- Affected units
- 49,130
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot number 11232311
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 9 recalled by Argon Medical Devices, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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